At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 28 enrolled
Drug / intervention
Epinephrine HFA-MDI (E004) +1 moredrug
Likely dose
Epinephrine HFA-MDI (E004) 125 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma (A Randomized, Double-Blind, Placebo-Controlled, Crossover, Single Dose Study in 4 - 11 Year Old Children With Asthma)
In Brief
A Phase 3 clinical trial evaluating Epinephrine HFA-MDI (E004) and Placebo-HFA for Asthma. Completed, enrolled 28 participants across 6 sites.
Detailed Summary
This is a multi-center, randomized, double-blinded, placebo-controlled, crossover, single dose study in 24 pediatric patients (4-11 years old) with asthma. The entire study consists of (i) a Screening Visit and (ii) a Study Period with two (2) Study Visits. All study subjects must be properly consented, under adult supervision, and screened against the inclusion and exclusion criteria, at the Screening Visit.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedNov 2012
Primary CompletionMar 2013
Study CompletionDec 2013
TodayJul 2026
First PostedNov 30, 2012
Enrollment StartOct 1, 2012
Primary CompletionMar 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.6 years ago
Interventions
Epinephrine HFA-MDI (E004)drug
Single dose 125 mcg/inhalation, 2 inhalations
Placebo-HFAdrug
Single dose 0 mcg/inhalation, 2 inhalations